Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
ConditionFeeding Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorBoston Children's Hospital
About this trial
The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.
Eligibility criteria
Qualifiers
age > 1 year
>90% of total calories via G-tube for > 6 months
G-tube diameter ≥ 14 French
moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score > 2
Disqualifiers
cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
Nissen fundoplication
use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
Trial design
Treatments tested in this trial
- Extremely thick blenderized tube feed
- Mildly thick blenderized tube feed
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov